{"product_id":"ich-gcp-e6-r3-updates-key-changes-impacting-clinical-investigators-sites-and-ind-holders-sponsor-investigators-and-institutions-2027-01-11","title":"ICH GCP E6 (R3) Updates: Key Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsor-Investigators and Institutions)","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe ICH GCP E6(R3) update introduces significant advancements to clinical trial management, emphasizing flexibility, efficiency, and risk-based approaches. This revision refines key areas such as investigator responsibilities, quality management, and trial oversight to better align with the complexities of modern clinical research. This web seminar will provide an in-depth look at the changes brought about by the R3 update, focusing on their impact on clinical investigators, trial sites, and Sponsors-Investigators. Topics will include the expanded responsibilities of investigators, sponsors, and institutions regarding oversight, monitoring plans, risk assessments, and data integrity. Learners will also explore practical strategies for updating organizational SOPs, processes, and staff training to ensure compliance with the new guidelines.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIdentify key changes affecting investigator responsibilities and roles under the ICH GCP E6(R3) guidelines\u003c\/li\u003e \u003cli\u003eExplain how the revisions impact clinical trial sites and Sponsors-Investigators\u003c\/li\u003e \u003cli\u003eEvaluate potential solutions for adapting organizational SOPs, processes, procedures, and staff training to the updated guidelines\u003c\/li\u003e \u003cli\u003eApply best practices for effective implementation of the ICH GCP E6(R3) guidelines in clinical trials\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eQuality Assurance\/Compliance Personnel\u003c\/li\u003e \u003cli\u003ePrincipal Investigators\/Sub-Investigators\u003c\/li\u003e \u003cli\u003eResearch Site Staff (Managers, CRCs, Data Managers\/Data Entry)\u003c\/li\u003e \u003cli\u003eManagers\/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management\u003c\/li\u003e \u003cli\u003eStudy Managers\/Project Managers, CRAs\/Monitors (Centralized, On-site)\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\u003c\/p\u003e\u003cp\u003eShelia Russell McCullers, M.S., D.M.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-030-L99-P. Released: 4\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53474477670765,"sku":"BI17618","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/ich-gcp-e6-r3-updates-key-changes-impacting-clinical-investigators-sites-and-ind-holders-sponsor-investigators-and-institutions-2027-01-11","provider":"Barnett International ","version":"1.0","type":"link"}